Malleolar Replacement Devices

ABSTRACT

A prosthesis and kit for replacing an ankle joint, and methods of applying the devices or systems. The prosthesis is an intramedullary device directed towards replacement of either of the tibia or fibula bone, wherein the prosthesis is a replacement for the lateral malleolus or the medial malleolus, respectively.

RELATED APPLICATIONS

The present application is a divisional application of U.S. patentapplication Ser. No. 13/178,208, filed on 7 Jul. 2011, and entitled“Malleolar Replacement Devices,” which claims the benefit of U.S.Provisional Application, Ser. No. 61/362,122, filed on 7 Jul. 2010,which are both incorporated by reference herein in their entireties.

BACKGROUND OF THE INVENTION

The invention relates to ankle replacement prostheses and systems, aswell as associated surgical instruments and procedures. The presentinvention is more specifically directed towards intramedullary anklejoint replacements.

Until the early- to mid-1970's, patients with injured or diseased anklejoints commonly resulting from rheumatism, or degenerative or traumaticarthritis, had few options when their ankle joints failed. The mostcommon procedure to help these patients regain some use of their anklewas obliteration of the joint by fusion, a procedure that is stillcommonly used today. Fusion, however, rendered the ankle stiff andgenerally immobile relative to the lower leg, resulting in limited useand additional stresses on the knee and hip joints.

Probably the first reported use of a total ankle prosthesis was byBuckholz in 1969. The medical community recognized that such anklereplacement led to largely increased use of the ankle joint because thereplacement permitted ankle ranges of motion which generally attemptedto mimic the natural human joint. Since that time, ankle replacementprostheses have become increasingly common in use and improved indesign.

Ankle fractures are particularly common in people having bone disease,such as osteoporosis. Geriatrics, particularly women, are verysusceptible to ankle fractures, and the prognosis after fracture isgenerally poor, even with the use of a prosthesis. In general, currentlyused prostheses do not afford the necessary flexibility required for anankle joint and recovery can be slow and arduous. The fusing together ofbones or bone segments required and carried out with prior prostheseslimits the ability of the ankle joint to completely heal properly,particularly with those who may have had limited mobility prior to theankle fracture.

Stability and weight bearing are other issues that are more importantwhen replacing an ankle joint as opposed to other joints. For example,hip, shoulder, or knee joints are not required to bear the load that issupported by an ankle joint. Consequently replacement devices for theseother joints do not necessarily translate to possible replacement jointsfor an ankle joint.

SUMMARY OF THE INVENTION

The present invention is directed towards a prosthesis and kit forreplacing an ankle joint, and methods of applying the devices orsystems. The prosthesis is an intramedullary device directed towardsreplacement of a portion of either a human tibia or fibula bone, whereinthe prosthesis is a replacement for the lateral malleolus or the medialmalleolus, respectively.

The device has a first end that is inserted into the intramedullarycanal of either the fibula or tibia. A second end of the device isshaped and configured to assimilate the shape of the lateral or medialmalleolus, respectively. The device will be secured to the respectivetibia or fibula. Likewise, a system could comprise two devices, whereinone is directed towards each of the tibia and fibula.

The invention also contemplates methods of installing or inserting thedevice, wherein the particular malleolus is resected, sufficiently orcompletely so that the device will replicate the contours of the boneonce inserted. The first end of the device is inserted into theintramedullary canal and secured to the bone.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an ankle joint.

FIG. 2 is a perspective view of the ankle joint of FIG. 1, with a breakbeing shown in the fibula bone.

FIG. 3A is a perspective view of an ankle replacement device accordingto the present invention.

FIG. 3B is a second perspective view of the device of FIG. 3A.

FIG. 4 is a side view of the device of FIG. 3A.

FIG. 5 is a view of the ankle of FIG. 2 showing an incision being madein the skin for eventual insertion of a prosthesis as shown in FIG. 3A.

FIG. 6 demonstrates a prosthesis being inserted into the incision ofFIG. 5 to determine a properly sized prosthesis.

FIG. 7 demonstrates the ankle of FIG. 2 being resected to prepare theankle for placement of the device of FIG. 3A within the ankle.

FIG. 8 depict the device of FIG. 3A being inserted into the fibula.

FIG. 9 depicts the device of FIG. 3A being affixed to the ankle.

FIG. 10 is a perspective view of the ankle of FIG. 1, with a break beingshown in the tibia bone.

FIG. 11A is a perspective view of a second ankle replacement deviceaccording to the present invention.

FIG. 11B is second perspective view of the device of FIG. 11A.

FIG. 12 is a side view of the device of FIG. 11A.

FIG. 13 is a view of the ankle of FIG. 10 showing an incision being madein the skin for eventual insertion of a prosthesis as shown in FIG. 11A.

FIG. 14 demonstrates a prosthesis being inserted into the incision ofFIG. 13 to determine a properly sized prosthesis.

FIG. 15 demonstrates the ankle of FIG. 10 being resected to prepare theankle for placement of the device of FIG. 11A within the ankle.

FIG. 16 depicts the device of FIG. 11A being inserted into the ankle.

FIG. 17 depicts the device of FIG. 11A being affixed to the ankle.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structures. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

FIG. 1 depicts a normal ankle joint, free of fracture. The anklegenerally consists of the distal ends of the fibula and tibia bones,which are connected to the talus bone. The fibula bone comprises thelateral malleolus, which is connected to the talus by way of the lateralligament. The tibia bone comprises the medial malleolus, which isconnected to the talus by way of the deltoid ligament. The tibia andfibula are connected two one another by way of the syndesmotic ligament.

If undue stress is put on the ankle joint, the joint may fracture, witheither the fibula or tibia fracturing, or possibly both. Often afracture will form at the proximal end of respective malleolus, e.g. thelateral or medial malleolus. Such a fracture of the lateral malleolus isshown in FIG. 2, wherein the fracture is shown on the fibula at theproximal end of the lateral malleolus.

FIGS. 3A-4 depict a prosthesis 100 according to the present invention toaddress a fracture, as shown, in FIG. 2. The prosthesis 100 generallycomprises a proximal portion 102 and a distal portion 104. The proximalportion 102 comprises an insert 106 adapted to be positioned within theintramedullary canal of the fibula. The proximal portion 102 preferablyhas a smaller diameter than the distal portion 104, so that when theinsert 106 is inserted into the intramedullary canal, there is adefinite distance that the prosthesis 100 may be inserted into theintramedullary canal. The insert 106 can be of any shape, e.g. a post,or wedge or multiple posts or wedges, that will allow the insert 106 tobe properly inserted and affixed within the intramedullary canal. Theinsert 106 has at least one hole 108 and preferably a plurality of holes108 that will allow screws 110 (see FIG. 7) to attach the prosthesis 100to the fibula. A plurality of holes 108 is preferable, in that it allowsfor the insert 106, and the prosthesis 100 in general, to be attached atvarying angles and elevations, depending on a particular fracture or onother characteristics, such as the age or gender of the patient.

Still referring to FIGS. 3A-4, the distal portion 104 generally forms abody 112 that is shaped and sized to follow the contours of the lateralmalleolus. The body 112 also has an opening 114, and preferably aplurality of openings 114. The openings 114 are generally used duringthe implantation of the prosthesis as an insertion guide whenpositioning the prosthesis. The openings 114 may also receive screws 110so that the distal portion 104 may also be attached to the joint by wayof screws 110 (see FIG. 7). As with the insert 106, it is preferable forthe body 112 to have a plurality of openings 114 so that the prosthesis100 can be positioned at varying angles and elevations. A through bore116 may also be located on the body, which can receive a pin forsyndesmotic fixation, if necessary.

The prosthesis 100 is also designed to provide protection for the ankleand surrounding tendons once the prosthesis 100 is inserted. Forexample, a flange or groove 118 is located in the body 112, which isintended to protect the peroneal tendon once the prosthesis is properlypositioned. The peroneal tendon will rest within the groove 118, therebyallowing the groove to act as a shield for the tendon. The body 112 mayhave a groove 118 on either the right side or the left side of the body112, or both sides of the body 112, which will allow the prosthesis tobe used for a right or left ankle repair.

FIGS. 5-9 depict the prosthesis 100 being secured to the fibula bone.Initially, a doctor, surgeon, or radiologist will take a radiograph orX-ray of the ankle to assist with making a template for the ankle and toassist in properly sizing a prosthesis to be used in the ankle repair.

FIG. 5 shows a doctor or surgeon preparing the fractured ankle of FIG. 2for insertion of the prosthesis 100. An incision over the lateralmalleolus will be cut into the skin of the ankle to thereby expose themalleolus. The tendons, e.g. the peroneal tendon, will be mobilized bythe surgeon.

FIG. 6 show a prosthesis 100 being inserted into the incision. Theprosthesis 100 is used as a trial implant to determine the appropriatesize for a prosthesis 100 that will eventually be inserted into theincision. The use of a trial implant will also assist in determining thenecessary level of bone resection that will be required for thefractured/comminuted bone.

FIG. 7 demonstrates the bone being resected for insertion of theprosthesis 100. An oscillating saw is used to cut the bone at the levelsof the trial implant (see FIG. 6). The bone is resected so that once theprosthesis 100 is positioned, it will follow the contours of the nativelateral malleolus. Similarly, the intramedullary canal will be resectedso that it will be shaped to receive the proximal portion 102 of theprosthesis. The resected bone fragments will be detached from theligamentous and tendon attachments so that the properly sized andconfigured cavity will remain within the ankle joint. The relevantcanal, e.g. the endosteal canal, will be enlarged with reamers on thelateral malleolus to insure proper alignment within the cavity. Theamount of bone material that will be resected will depend on the sizeand severity of the fracture.

FIG. 8 shows the proximal portion 102 of the prosthesis 100 beinginserted into the intramedullary canal so that it may be affixed to thefibula. The prosthesis 100 will be inserted so that it is properlyaffixed to the fibula, but also to protect the peroneal tendon with theuse of the posterior groove 118 (see FIG. 4). The tendon will sit withinthe groove 118, thereby allowing the groove 118 to protect the tendon.Similarly, as shown in FIG. 8, enough of the lateral malleolus remainsaround the prosthesis 100 so that the prosthesis 100 is retainedproperly, which will prevent the prosthesis from unnecessarily movingfrom side to side once positioned in the ankle.

Once properly inserted, the prosthesis will mimic the shape and contourof a portion of the fibula, particularly the lateral malleolus, as shownin FIG. 9. The prosthesis 100 than can be secured to the ankle jointusing screws 110. Preferably, the prosthesis 100 is locked in place bysecuring one or more, e.g. two, screws 110 laterally through fibula, thesyndesmosis, and locking the screws to the tibia. Alignment guides maybe used to assist insertion of the screws. Screws 110 will also be usedto secure the distal portion 104 properly within the lateral malleolus.The resultant arrangement allows for a repaired ankle that will closelyresemble the fibula bone prior to fracture, thereby decreasing theamount of time needed for recovery and increasing the chance that thepatient will recover mobility and stability of the ankle.

As noted above, a fracture may also occur in the tibia as opposed to, orin addition to, the fibula. Such a fracture is depicted in FIG. 10. Sucha fracture typically happens at the proximal end of the medialmalleolus. FIGS. 11A-12 show a prosthesis 200 according to the presentinvention for addressing fractures as shown in FIG. 10. The prosthesis200 is similar to the prosthesis 100 described above in FIG. 3A-4,except that the prosthesis 200 is directed towards a fracture of thetibia as opposed to the fibula. That is, the prosthesis 200 is designedto be shaped according to the contours of the medial malleolus asopposed to the lateral malleolus.

Still referring to FIGS. 11A-12, the prosthesis comprises a proximalportion 202 and a distal portion 204. The proximal portion comprises aninsert 206 that will be inserted into the intramedullary canal of thetibia. As with the prosthesis 100, the proximal portion 202 preferablyhas a smaller diameter than the distal portion 204, so that when theinsert 206 is inserted into the intramedullary canal, there is adefinite distance that the prosthesis 200 may be inserted into theintramedullary canal. The insert 206 can be of any shape, e.g. a post orwedge or multiple posts or wedges, that will allow the insert 206 to beproperly inserted and affixed within the intramedullary canal. Theinsert 206 has a hole 208 or plurality of holes 208 for attachment tothe tibia by way of screws 210 (see FIG. 13). A plurality of holes 208is preferable, in that it allows for the insert 206, and the prosthesis200 in general, to be attached at varying angles and elevations,depending on a particular fracture or on other characteristics, such asthe age or gender of the patient.

Still referring to FIGS. 9A-10, the distal portion 204 of the prosthesis200 generally forms a body 212 that is shaped and sized to follow thecontours of the medial malleolus. The body 212 also has an opening 214,and preferably a plurality of openings 214. The openings 214 aregenerally used during the implantation of the prosthesis as an insertionguide when positioning the prosthesis. The openings 214 may also receivescrews 210 so that the distal portion 204 of the prosthesis 200 may alsobe attached to the ankle joint by way of screws 210 (see FIG. 7). Aswith the insert 206, it is preferable for the body 212 to have aplurality of openings 214 so that the prosthesis 100 can be positionedat varying angles and elevations. A through bore 216 may also be locatedon the body, which can receive a pin for syndesmotic fixation, ifnecessary.

The prosthesis 200 is also designed to provide protection for the ankleand surrounding tendons, e.g. posterior tibial tendon, once theprosthesis 200 is inserted. For example, a flange or groove 218 islocated on the body 212, which is intended to protect the posteriortibial tendon once the prosthesis is properly positioned. The posteriortibial tendon will rest within the groove 218, thereby allowing thegroove to act as a shield for the tendon. The body 112 may have a groove218 on either the right side or the left side of the body 212, or bothsides of the body 212, which will allow the prosthesis to be used for aright or left ankle repair.

FIGS. 13-17 depict the prosthesis 200 being secured to the tibia bone.Initially, a doctor, surgeon, or radiologist will take a radiograph orX-ray of the ankle to assist with making a template for the ankle and toassist in properly sizing a prosthesis to be used in the ankle repair.

FIG. 13 shows a doctor or surgeon preparing the fractured ankle of FIG.10 for insertion of the prosthesis 200. An incision over the medialmalleolus will be cut into the skin of the ankle to thereby expose themalleolus. The tendons, e.g. the posterior tibial tendon, will bemobilized by the surgeon.

FIG. 14 show a prosthesis 200 being inserted into the incision. Theprosthesis 200 is used as a trial implant to determine the appropriatesize for a prosthesis 200 that will eventually be inserted into theincision. The use of a trial implant will also assist in determining thenecessary level of bone resection that will be required for thefractured/comminuted bone.

Referring to FIG. 15, the tibia bone is resected so that once theprosthesis 200 is positioned within the intramedullary canal, it willfollow the contours of the native medial malleolus. An oscillating sawis used to cut the bone at the levels of the trial implant (see FIG.14). In the same fashion, the intramedullary canal will be resected sothat it will be shaped to properly receive the proximal portion 202 ofthe prosthesis. The resected bone fragments will be detached from theligamentous and tendon attachments so that the properly sized andconfigured cavity will remain within the ankle joint. The relevantcanal, e.g. the endosteal canal, will be enlarged with reamers on themedial malleolus to insure proper alignment within the cavity. Theamount of bone material that will be resected will depend on the sizeand severity of the fracture.

FIG. 16 shows the proximal portion 202 of the prosthesis 200 beinginserted into the intramedullary canal so that it may be affixed to thetibia. Once properly inserted, the prosthesis 200 will mimic the shapeand contour of a portion of the tibia, particularly the medialmalleolus, as shown in FIG. 17. The prosthesis 200 than can be securedto the ankle joint using screws 210. One or more screws 210, e.g. threescrews 210, preferably with the screws 210 being in the form of offsetscrews, will pass through the medial mallelolar cortex, through theintramedullary canal, and ending in the distal side of the tibia, e.g.the tibial metaphysic. The arrangement helps to promote boney in-growthinto the prosthesis, thereby increasing the recovery and stability ofthe repaired ankle. The resultant arrangement allows for a repairedankle that will closely resemble the tibia bone prior to fracture,thereby decreasing the amount of time needed for recovery and increasingthe chance that the patient will recover mobility and stability of theankle.

The prosthesis 200 will be inserted so that it is properly affixed tothe tibia, but also to protect the posterior tibial tendon with the useof the posterior groove 218 (see FIG. 12). The tendon will sit withinthe groove 218, thereby allowing the groove 218 to protect the tendonand also to prevent the prosthesis from unnecessarily moving from sideto side once positioned in the ankle.

As such, the present invention is directed towards a prosthesisgenerally comprising a proximal portion, that will be inserted into theintramedullary canal of a specific bone of the ankle joint, and a distalportion that is shaped and designed to replicate the malleolus sectionof the particular bone that the prosthesis is used in connection with.By using the prostheses to replicate the shape and form of the boneprior to fracture, these prostheses increase the stability of the anklejoint and also decrease the recovery time, as the ankle joint is capableof bearing weight sooner than prior art devices. Similarly, theintramedullary design also promotes healing and recovery, in that itfosters grafting of the prosthesis to the bone.

The prostheses of the present invention may be made of any suitablebiocompatible material. Preferably the prostheses are made of a materialthat will help with in bone growth. A porous material, e.g. sinteredtitanium, is one preferred material. For example, the prosthesis 100,200 may have a titanium porous coating, which assists in bone growth.

It should also be understood that, if necessary, the present inventioncontemplates a kit that will include both a prosthesis 100 for use withthe fibula and a prosthesis 200 for use with the tibia. However, one ofthe advantages of the present invention over the prior art is that it isnot necessary that both the fibula and tibia be resected if one of thebones is not fractured. The prostheses are inserted and attachedindependently from one another, which also provides for a more efficientreconstruction process for the ankle joint, since alignment of separateprostheses for the fibula and tibia during surgery is not necessary.Likewise, it should be understood that the use of screws 110, 210 refersgenerally to attachment means for the ankle, e.g. pins, bolts, screws,clamps, etc., that are commonly used in surgical procedures. It is alsounderstood that the length of the screws 210, 110 is determinative onthe needs of a particular fracture, including such factors as age of theperson requiring the prosthesis. For example, a screw may besufficiently long so that the screw will intersect syndesmotic ligament,or it may be determined that a shorter screw will be sufficient. Anylength of screw 210 or other fastening device will fall within the scopeof the present invention.

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

We claim:
 1. An ankle prosthesis comprising: a proximal portion adaptedfor insertion into an intramedullary canal of one of a human tibia and ahuman fibula; and a distal portion coupled to the proximal portion, thedistal portion shaped similarly to a malleolus of the one of a humantibia and a human fibula, wherein said distal portion further includes agroove configured to receive a tendon associated with a human ankle. 2.The ankle prosthesis of claim 1 further comprising at least one holelocated in said distal portion, said at least one hole capable ofreceiving means for attaching the prosthesis to the ankle.
 3. The ankleprosthesis of claim 2 further comprising a plurality of holes located insaid distal portion, said holes capable of receiving means for attachingthe prosthesis to the ankle.
 4. The ankle prosthesis of claim 1 furthercomprising at least one hole located in said proximal portion, said atleast one hole capable of receiving means for attaching the prosthesisto the one of a human tibia and a human fibula.
 5. The ankle prosthesisof claim 4, further comprising a plurality of holes located in saidproximal portion, said holes capable of receiving means for attachingthe prosthesis to the one of a human tibia and a human fibula.
 6. Theankle prosthesis of claim 1 wherein the distal portion has a largercross-sectional diameter than said proximal portion.
 7. The ankleprosthesis of claim 6, wherein the proximal portion comprises an insertthat defines a distance that the proximal end may be inserted into theintramedullary canal.
 8. The ankle prosthesis of claim 1, wherein thedistal portion is coupled to the proximal portion by being integrallyformed therewith.
 9. The ankle prosthesis of claim 1, wherein theproximal portion is adapted for insertion into the intramedullary canalof the human tibia and the tendon comprises the posterior tibial tendon.10. The ankle prosthesis of claim 1, wherein the proximal portion isadapted for insertion into the intramedullary canal of the human fibulaand the tendon comprises the peroneal tendon.
 11. The ankle prosthesisof claim 1, wherein the distal portion comprises a through boreconfigured to receive a pin for syndesmotic fixation to the ankle. 12.The ankle prosthesis of claim 1, wherein the proximal portion and distalportion comprise a porous material.
 13. The ankle prosthesis of claim12, wherein the porous material comprises titanium.
 14. The ankleprosthesis of claim 13, wherein the titanium is sintered titanium. 15.The ankle prosthesis of claim 13, wherein the titanium comprises atitanium porous coating.